6 completed, 1 terminated. 7 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 6, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 1 | Completed 1 |
Follow Afibrinogenemia: new trials by email Literature Review of Afibrinogenemia trials Research Report on Afibrinogenemia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness FibCLOT, RiaSTAP - Hypofibrinogenemia, Surgical Blood Loss | Phase 2 | Completed | IRCCS Policlinico S. Donato | 40 | 2023-03-20 | 2024-02-28 |
| ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Fibrinogen Concentrate Human, Prothrombin Complex Concentrate, Fresh Frozen Plasma - Bleeding, Cardiac Defect | Phase 2 | Terminated | IRCCS Policlinico S. Donato | 40 | 2020-02-27 | 2021-11-03 |
| Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia Human Plasma-Derived Fibrinogen Concentrate - Congenital Afibrinogenemia | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 24 | 2016-07-22 | 2022-03-31 |
| Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST) Fibrinogen concentrate, Placebo Comparator - Trauma, Injury | Phase 1 / Phase 2 | Completed | Sunnybrook Health Sciences Centre | 50 | 2014-10-01 | 2016-04-14 |
| Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency biological: human fibrinogen concentrate - Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital | Phase 2 / Phase 3 | Completed | Laboratoire français de Fractionnement et de Biotechnologies | 16 | 2014-01-01 | 2016-02-12 |
| Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap Octafibrin, Haemocomplettan® P or RiaSTAPTM - Congenital Fibrinogen Deficiency, Afibrinogenemia | Phase 2 | Completed | Octapharma | 22 | 2013-06-01 | 2018-03-09 |
| Human Fibrinogen - Pharmacokinetics Human Fibrinogen Concentrate - Fibrinogen Deficiency | Phase 2 | Completed | CSL Behring | 15 | 2007-07-01 | 2016-09-15 |
Hemorrhage (3) · Blood Loss, Surgical (1) · Heart Defects, Congenital (1) · Heart Diseases (1) · Hemophilia B (1) · Hemostatic Disorders (1) · Postoperative Hemorrhage (1) · Transfusion Reaction (1) · Transfusion-Related Acute Lung Injury (1) · Wounds and Injuries (1)
Blood Coagulation Disorders (7) · Blood Coagulation Disorders, Inherited (7) · Coagulation Protein Disorders (7) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (7) · Genetic Diseases, Inborn (7) · Hematologic Diseases (7) · Hemic and Lymphatic Diseases (7) · Hemorrhagic Disorders (7) · Cardiovascular Diseases (3) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Acute Lung Injury (1) · Cardiovascular Abnormalities (1) · Congenital Abnormalities (1) · Genetic Diseases, X-Linked (1)
Fibrinogen (4) · Factor IX (1) · Saline Solution (1)
IRCCS Policlinico S. Donato (2) · CSL Behring (1) · Grifols Therapeutics LLC (1) · Laboratoire français de Fractionnement et de Biotechnologies (1) · Octapharma (1) · Sunnybrook Health Sciences Centre (1)
Italy (4) · United States (3) · India (2) · Lebanon (2) · Bulgaria (1) · Canada (1) · France (1) · Iran (1) · Morocco (1) · Switzerland (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Marco Ranucci, MD (2) · Barto Nascimento, MD MSc (1) · Flora Peyvandi, MD (1) · Sigurd Knaub, PhD (1)